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Requirements for Water treatment in Hospitals

DIN EN 285 sets quality standards for sterile goods processing that also take into account the quality of the water used.

Water treatment systems must ensure that the produced demineralized water for the processes meets these requirements. However, the DGSV recommends stricter limit values.

The German Society for Sterile Supply (DGSV) is an organization that deals with sterile supply in healthcare facilities. Its guidelines and recommendations primarily concern the handling of sterile supplies, including the reprocessing of medical devices and equipment.

The DGSV emphasizes the importance of quality assurance and traceability in the reprocessing of medical devices. Precise documentation of the water quality of each batch is essential to ensure compliance with the prescribed standards and to guarantee patient safety. These measures help to keep processes transparent and to quickly identify and eliminate possible sources of error. Complete documentation makes a significant contribution to quality assurance and ensures that hygiene regulations are complied with.

Well-founded training and competence of the personnel are essential in the reprocessing of medical devices. Every employee must be able to recognize the effects of deviations in water quality and take the necessary action.


How to treat water

A system for producing demineralized water, which is used as process water in the treatment, is a combination of several components. The DGSV expert committee describes the individual stages of optimal water treatment in detail in its recommendation no. 17.

Water treatment according to the guidelines of the DGSV

Water treatment in hospitals, outpatient centers and medical practices

Requirements for water treatment
  • Quantity of demineralized water required
  • Limit values according to guidelines (DGSV)
  • Traceability of batches
  • Qualification of personnel
  • Protection of instruments & devices
Sterile goods cycle
Sterile goods cycle
Limits

Contemporary new limit values according to DGSV
The Instrument Preparation Working Group (AKI) is already calling for stricter limits for water quality in its Red Brochure for 2017.

Parameter DIN EN 285 DGSV expert committee
Conductivity up to 25°C ≤ 5 μS/cm ≤ 1 μS/cm
Silicate ≤ 1 mg/l ≤ 0.4 mg/l
Water quality has an influence on...
  • Cleaning result
  • disinfection result
  • visual appearance of surfaces
  • sterilization result
  • Maintenance of the value of medical products and devices
  • Piping system / fittings
  • Effectiveness of process chemicals
Guidelines, standards

IfSG UVV TRBA/BGR 250
ArbMedVV ISO DIN EN 15883
MDR ISO DIN EN 17664
ISO DIN EN 285 ISO DIN EN 11140-4

Parameters

pH SiO2
°dH µS/cm

This is how water treatment works
How water treatment works
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